Investigating the effect of quercetin on the severity of dermatitis caused by radiotherapy in patients with breast cancer
Design
Clinical trial with a control group, with parallel groups, Triple-blind, randomized, phase 3 on 92 patients. Sealedenvelop.com was used for randomization.
Settings and conduct
The study is conducted in Shahid Rajaei Hospital, Babolsar. Medicines are placed in tubes of the same shape and without the researcher and the patient knowing the contents of each tube, medicines are given to patients with the help of a nurse. Group 1 receives quercetin and the control group receives placebo. Patients are asked to apply the medicine twice a day after each radiotherapy session (once after radiotherapy and once at night).
Participants/Inclusion and exclusion criteria
Women with breast cancer in the age range of 30 to 70 years who underwent surgery and chemotherapy and after 3 to 4 weeks of chemotherapy, referred to Shahid Rajaei Hospital in Babolsar, Mazandaran province to receive adjuvant radiotherapy, were included in the study. Patients who have an underlying disease and a history of inflammatory skin disease, or are in stage 4 ,have undergone radiotherapy for palliation or have a history of severe drug sensitivity are excluded from the study.
Intervention groups
Medicines are placed in tubes of the same shape. Group 1 receives quercetin and the control group receives placebo. Patients are asked to apply the medicine twice a day after each radiotherapy session (once after radiotherapy and once at night).
Main outcome variables
The severity of dermatitis caused by radiotherapy based on the RTOG classification, the time of onset or change in the intensity of symptoms and the intensity of pain in patients based on the Visual Analogue Scale index.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230509058138N1
Registration date:2023-12-18, 1402/09/27
Registration timing:prospective
Last update:2023-12-18, 1402/09/27
Update count:0
Registration date
2023-12-18, 1402/09/27
Registrant information
Name
Maryam Ramezanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
m.ramzanpoor@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the intensity of dermatitis caused by radiotherapy in breast cancer patients with or without using quercetin
Public title
The effect of quercetin on dermatitis caused by radiotherapy in breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with breast cancer who are between 30 to 70 years old
they underwent breast lumpectomy surgery
after 3-4 weeks of surgury, they came for radiotherapy
Exclusion criteria:
patients who have an underlying disease and a history of skin inflammation
patients who are in stage 4 or are undergoing radiotherapy for palliation
patients with Modified Radical Mastectomy must not be included in the study.
Patients with a history of severe allergy
Age
From 30 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
During this double-blind randomized clinical trial, patients are divided into two random groups using blocks 4 and 10. Medicines are placed in tubes of the same shape and without the researcher and the patient knowing the contents of each tube, the medicines are given to the patients with the help of a nurse.
Blinding (investigator's opinion)
Triple blinded
Blinding description
During this double-blind clinical trial, the participants (patients), the researcher, the outcome assessor and the data analyst have been kept blind. Ointments containing Quercetin and placebo are placed in tubes of the same shape, by a colleague not involved in the implementation process of the project, and without the researcher and the patient knowing the contents of each tube, the medicines are given to the patients with the help of a nurse.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Health Research Institute - Babol University of Medical Sciences
Street address
Gangafrouz Ave., Abolhasani Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2023-12-10, 1402/09/19
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.134
Health conditions studied
1
Description of health condition studied
Dermatitis
ICD-10 code
L58.0
ICD-10 code description
Acute radiodermatitis
Primary outcomes
1
Description
Severity of radiotherapy-induced dermatitis according to RTOG classification
Timepoint
The severity of radiation dermatitis is evaluated once a week from the time of entering the study until the completion of the radiotherapy treatment.
Method of measurement
Based on the criteria of Radiation Therapy Oncology Group
Secondary outcomes
1
Description
The time which symptoms of dermatitis develop
Timepoint
Once a week from the beginning of the study to the end of the radiotherapy duration
Method of measurement
We record the time when the symptoms of dermatitis developed in the weekly examination according to the opinion of the specialist who evaluates the patients.
2
Description
Severity of patients' pain
Timepoint
Once a week from the beginning of the study to the end of the radiotherapy duration
Method of measurement
We record the change in pain intensity in the weekly examination according to the opinion of the specialist who evaluates the patients. The pain intensity of the patients is measured using the Visual Analogue Scale index.
Intervention groups
1
Description
Intervention group: Women with breast cancer in the age range of 30 to 70 years who underwent surgery (lumpectomy) and chemotherapy and after 3 to 4 weeks of chemotherapy, referred to receive adjuvant radiotherapy, are included in the study. The combination of quercetin from Sigma company is given to patients at a dose of 0.2%. After each radiotherapy session, patients are asked to apply the drug twice a day (once after radiotherapy and once at night) for 6 weeks using rubbing method. Also, before each radiotherapy session, patients should use Dove soap to wash the treatment area so that no trace of the drug remains.
Category
Treatment - Drugs
2
Description
Control group: The placebo contains carboxymethyl cellulose with food coloring that is similar in color to the quercetin compound. After each radiotherapy session, patients are asked to apply the drug twice a day (once after radiotherapy and once at night) for 6 weeks using rubbing method. Also, before each radiotherapy session, patients should use Dove soap to wash the treatment area so that no trace of the drug remains.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei hospital
Full name of responsible person
Dariush Moslemi
Street address
Shariati Ave., Pasdaran Blvd., Babolsar Town
City
Babolsar
Province
Mazandaran
Postal code
47419-99879
Phone
+98 11 3527 1790
Fax
Email
moslemid@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr mehdi Rajabnia
Street address
Gangafrouz Ave., Abolhasani Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
moslemid@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maryam Ramezanpour
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Radiotherapy
Street address
Gangafrouz Ave., Abolhasani Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 21 8846 2826
Email
maryam.rmp81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dariush Moslemi
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Gangafrouz Ave., Abolhasani Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 2523 1517
Fax
Email
moslemid@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dariush Moslemi
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Gangafrouz Ave., Abolhasani Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 2523 1517
Email
moslemid@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available